Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

Not Applicable

Completed

• Conditions: Type II Diabetes

• Registration Number: NCT01698528
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2017-04-20
• Results First Submitted QC: 2017-08-16
• Results First Posted: 2017-09-14
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-28
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic Control as Determined by the Change in Absolute HbA1c Level	3 months	The primary outcome of interest is absolute decrease in A1c by end of 3 months.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reaching Target of HbA1c ≤ 7%	3 months	Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
Number of Participants With Hypoglycemia	3 months	Number of participants had hypoglycemia during the trial period
Change in Average Participation Satisfaction	3 months	The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.
Time Health Care Providers and Subjects Spend on Managing the Insulin Titration	3 months	time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States